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BioAtla Appoints Eric Sievers, M.D., As Chief Medical Officer

On June 28, 2019 BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported the appointment of Eric L. Sievers, M.D., as chief medical officer (Press release, BioAtla, JUN 28, 2019, View Source [SID1234537333]). Dr. Sievers, an experienced biotechnology drug developer in oncology, joins the Company bringing clinical development and management experience directly relevant to BioAtla’s oncology focus and pipeline of Conditionally Active Biologic (CAB) candidates including in immuno-oncology and antibody drug conjugates (ADCs). His clinical development leadership, design and execution resulted in several successful oncology registration trials and approvals including, for Seattle Genetics, approvals of ADCETRIS in Hodgkin lymphoma, in peripheral T-cell lymphoma, and in cutaneous T-cell lymphoma.

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"Dr. Sievers’ experience and proven capabilities in leading the clinical development of innovative oncology products greatly enhances BioAtla’s ability to design, implement, and execute clinical programs evolving from our CAB platform that uniquely yields tumor-targeting antibodies with high safety," said Jay M. Short, Ph.D., chairman and chief executive officer of BioAtla.

"Dr. Sievers’ knowledge of and background in developing advanced biologics including ADC’s, and his experience in leading partnership interactions with pharmaceutical company partners is directly applicable to our current and future product and strategic plans," stated Scott Smith, president of BioAtla.

About Dr. Sievers
Dr. Sievers joins BioAtla with over 25 years of clinical and translational biomedical research experience in multiple settings, including biotechnology industry, hospital- and clinic-based clinical practice and academics. During his nine years at Seattle Genetics, he was closely involved with the development and regulatory approval of ADCETRIS (brentuximab vedotin), an ADC. Serving in multiple roles of increasing leadership responsibility, he led the Seattle Genetics clinical team and Takeda (Millennium) development partner to design, initiate and enroll four randomized Phase 3 registration trials for ADCETRIS that each ultimately resulted in new indications approved by the FDA. Dr. Sievers has managed clinical development efforts from Phase 1 to Phase 3 clinical trials, from strategy planning to study execution and BLA/NDA submissions. Prior to his career at Seattle Genetics, Dr. Sievers was Medical Director at ZymoGenetics where he designed and supervised clinical trials of recombinant human interleukin 21 and TACI-Fc5 for patients with cancer and evaluated new oncology opportunities. Before then, he was with the Fred Hutchinson Cancer Research Center for 12 years where he attained the position of Assistant Member and was Assistant Professor of Pediatrics at the University of Washington. During this time, he served as the lead investigator of Phase 1 and pivotal trials that resulted in the approval of an antibody drug conjugate MYLOTARG indicated for patients with acute myeloid leukemia. Dr. Sievers’ most recent position was Chief Medical Officer at Trillium Therapeutics where he developed clinical trial strategies and oversaw all clinical development employing a decoy receptor to block the CD47 "do not eat" signal overexpressed by cancer cells. Dr. Sievers received both his medical degree and his B.A. degree from Brown University.

About Conditionally Active Biologics (CABs)
Conditionally Active Biologics are proteins generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

Menarini Ricerche Announces Publication of Pre-clinical Data of the First-in-class Antibody-drug Conjugate MEN1309/OBT076, Currently in Phase I Clinical Development

On June 28, 2019 Menarini Ricerche reported the publication of the results of a non-clinical study describing the characterization of the anti-CD205 Antibody-Drug Conjugate (ADC) MEN1309/OBT076. These findings have been published by the journal Molecular Cancer Therapeutics (View Source) (Press release, Menarini, JUN 28, 2019, View Source [SID1234537332]).

The study showed that CD205, a transmembrane glycoprotein, is robustly expressed in a variety of solid malignancies, such as pancreatic and bladder tumors, as well as triple negative breast cancer (TNBC). In these settings, MEN1309/OBT076 showed substantial in vitro antitumor activity. These results were confirmed in vivo where MEN1309/OBT076 demonstrated potent antitumor activity in TNBC, pancreatic, and bladder xenografts and patient-derived PDX models, resulting in durable responses and complete tumor regressions.

"These non-clinical data show the promising activity of MEN1309/OBT076 in solid tumors expressing CD205, thus supporting the clinical development of MEN1309, which is being evaluated in the phase I SHUTTLE study" (NCT03403725), said Monica Binaschi, PhD, Director of the Preclinical and Translational Sciences Department of Menarini Ricerche. "Moreover, these results provide a strong rationale for one of the key elements of the clinical development strategy of MEN1309/OBT076, represented by the specific targeting of patients with tumors expressing CD205 as confirmed by an appropriate assay developed in-house. The published study represents an example of fruitful scientific collaboration between academic centers of excellence in oncology research and industry, involving Joaquin Arribas and his team at the Vall D’Hebron Institute of Oncology (VHIO) in Barcelona, as well as our partner Oxford BioTherapeutics (OBT)."

About MEN1309/OBT076

MEN1309/OBT076, is an ADC comprising a fully human antibody targeting CD205, coupled to the DM4 toxin. MEN1309/OBT076 is in development for a number of CD205-driven tumors.

MEN1309/OBT076 is currently in development with a multicenter first-in-human clinical study in major European oncology centers in Italy, Spain, Belgium and UK, (NCT03403725) to evaluate the activity of the antibody in the treatment of metastatic solid cancers, including gastric cancer, triple-negative breast cancer, bladder cancer and pancreatic cancers as well as non-Hodgkin lymphoma (NHL). This clinical trial follows a precision oncology approach, key component of Menarini’s strategy, recruiting only patients positive for the expression of the therapeutic target CD205. Dose-Escalation phase I clinical trial is starting in the United States in highly experienced academic centers under the sponsorship of OBT.

Janssen Receives Positive CHMP Opinion Recommending Expanded Use of Imbruvica®▼(ibrutinib) in Two Indications in Europe

On June 28, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Imbruvica (ibrutinib) in two indications (Press release, Johnson & Johnson, JUN 28, 2019, View Source [SID1234537331]). One recommendation is for the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL).1 The second is for use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).1

Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies, said: "This is an important step forward in further enhancing our ability as haematologists to meet the treatment needs of more patients with these complex blood cancers. Ibrutinib has already offered important progress in both CLL and WM in the indications for which it is currently approved, and these new combination regimens show the potential to further extend the remission period for patients versus standard of care."

The Positive Opinion for CLL was based on results from the Phase 3 iLLUMINATE (PCYC1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.2 After a median follow-up of 31.3 months (interquartile range [IQR] 29.4–33.2), median progression-free survival (PFS) was significantly longer in the ibrutinib plus obinutuzumab group (median not reached [95 percent confidence interval [CI] 33.6–non-estimable]) than in the chlorambucil plus obinutuzumab group (19.0 months [15.1–22.1]; hazard ratio 0.23; 95 percent CI 0.15–0.37; p<0.0001).2

In WM, the Positive Opinion was supported by data from the Phase 3 iNNOVATE (PCYC-1127) study, presented at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2018. The study evaluated the safety and efficacy of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3 At a median follow up of 30.4 months, a significant improvement in the Independent Review Committee (IRC)-assessed primary endpoint of PFS was seen with ibrutinib plus rituximab when compared with placebo plus rituximab (estimated 30-month PFS rates were 79 percent vs. 41 percent, respectively).3

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).4,5

"We are incredibly encouraged by these CHMP recommendations, which represent our continued commitment to develop chemotherapy-free combinations for those living with CLL and WM," said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag France. "Ibrutinib has been used to treat more than 140,000 patients worldwide and we are continuing to deliver on our ambition to optimise outcomes for patients with complex B-cell malignancies, that have in the past been very difficult to treat."

Both Positive Opinions will now be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Dr Alessandra Tedeschi is co-investigator in both the iNNOVATE and iLLUMINATE studies. She was not compensated for any media work.

#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.6 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.7

Ibrutinib is currently approved in Europe for:8

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell lymphoma.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
Ibrutinib is approved in more than 95 countries, and, to date, has been used to treat more than 140,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.8

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.9 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.10 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.11

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).12 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.13 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.14 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.12,14.

Biodesix to Acquire Oncimmune in the United States

On June 28, 2019 Biodesix, Inc. reported that it will extend the company’s blood-based lung cancer diagnostic portfolio with acquisition of Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the United States (Press release, Biodesix, JUN 28, 2019, View Source [SID1234537330]). The United Kingdom-based company’s U.S. operations, including a CLIA lab in De Soto, Kansas, will transition to Biodesix on November 1, 2019. The lab is the sole U.S. provider of Oncimmune’s EarlyCDT -Lung test.

"Oncimmune’s extensive experience and patent portfolio in autoantibodies, and their relationship to cancer, attracted us to evaluate the use of Oncimmune’s EarlyCDT Lung test as a strategic addition to our diagnostic test offering in the U.S.," said David Brunel, CEO of Biodesix. "Biodesix is the leader in blood-based diagnostic solutions for lung cancer that provide actionable results and reimbursement with best-in-class turnaround time. Our Nodify XL2 test is used to help rule-out malignancy in low-to-moderate risk incidental lung nodules. EarlyCDT Lung is a rule-in test for lung cancer risk, and a natural and important extension of our commitment to care in the early disease setting."

Each year 1.6 million Americans are diagnosed with incidental lung nodules. Most of these nodules are benign, but the EarlyCDT Lung test helps identify those that could be cancerous. The blood-based lung nodule test enables earlier intervention by helping clinicians detect lung cancer at all stages of disease (I-IV). The extensively validated proteomic test measures seven autoantibodies to tumor-associated antigens created by the body’s response to cancer.

In addition to the lung nodule indication, the Early Cancer Detection Test – Lung Cancer Scotland (ECLS) study, a 12,210 patient study investigating the utility of the EarlyCDT Lung test in lung cancer screening, recently announced meeting primary end-points. ECLS is believed to be the largest randomized controlled study using biomarkers for detection of lung cancer and could lead to a future screening indication for the EarlyCDT Lung test. Full results from the study will be published in a peer-reviewed publication later this year.

"The addition of EarlyCDT Lung to the Biodesix portfolio will allow more patients to benefit from this unique diagnostic tool," said Scott Hutton, COO of Biodesix. "The Nodify XL2 and EarlyCDT Lung tests complement each other to help provide physicians with the ability to stratify patients into distinct nodule management pathways."

"This agreement is a significant milestone for Oncimmune," said Adam M. Hill, MD Ph.D, CEO of Oncimmune. "Like us, Biodesix is committed to developing and delivering lung cancer diagnostic solutions to improve patient outcomes. EarlyCDT Lung is highly complementary to Nodify XL2 to help guide treatment decisions, and Biodesix is an excellent partner for Oncimmune in the U.S. market."

Additional terms of the agreement provide that Biodesix will make milestone payments to Oncimmune upon achieving certain commercial objectives. In addition, Oncimmune will continue to collaborate with Biodesix on new strategic endeavors to improve patient outcomes in lung cancer.

Annual Report for the Year Ended December 31, 2018

On June 28, 2019 Verseon (AIM:VERS), the clinical-stage pharmaceutical company developing disruptive life-science technologies to advance global health, reported its Final Results for the year ended December 31, 2018 (Press release, Verseon, JUN 28, 2019, View Source [SID1234537329]). The report and accounts are available for download from the Company’s website (www.verseon.com).

Adityo Prakash, CEO of Verseon Corporation, commented: "In 2018, we reached a major milestone with our first drug program entering clinical trials. The phase 1 study of VE-1902, our lead precision oral anticoagulant (PROAC), is ongoing with first results expected in Q4 2019. We have also nominated our first development candidate for the oral treatment and prevention of diabetic macular edema, and launched a new discovery program focusing on the treatment of metabolic disorders."

"Heading into 2019, we remain committed to advancing drug development and improving patients’ lives through our active clinical trials program, growing number of novel drug candidates, and our robust and diversified pipeline."

Highlights
Finance

Results for the year ended December 31, 2018:

Total assets on the balance sheet stood at $56.4 million, compared to $54.2 million at the end of 2017.
Cash, cash equivalents, and short-term investments stood at $3.6 million, compared to $11.6 million at the end of 2017.
Property, equipment, buildings, and land totaled $51.3 million, compared to $40.7 million at the end of 2017.
Research and development expenses were $13.8 million, compared to $15.1 million in 2017.
General and administrative expenses were $8.0 million, compared to $6.3 million in 2017.
Non-cash expenses include stock-based compensation of $1.7 million, compared to $0.9 million in 2017 and also a currency exchange loss of $4 thousand, compared to a gain of $0.6 million in 2017.
Net loss was $21.6 million or $0.14 per basic share, compared to a net loss of $20.4 million or $0.13 per basic share in 2017.
Going concern

The Company’s financials have been prepared on a going concern basis, and the rationale for this is discussed in the footnotes to the financial statements under Note D, Summary of Significant Accounting Policies.
Anticoagulation

VE-1902, our first precision oral anticoagulant (PROAC) for long-term anticoagulant-antiplatelet combination therapy, entered phase 1 clinical trials.
A second PROAC, VE-2851, is also advancing toward clinical trials in 2020.
Diabetic macular edema

We nominated the first development candidate for clinical trials in our oral diabetic macular edema program.
The development candidate VE-4839 is expected to enter phase 1 in H1 2020.
Hereditary angioedema

Our oral drugs for this rare, potentially life-threatening disease, continue to show good potency and pharmacokinetics.
Oncology

In preclinical testing, our new anticancer agents for the treatment of multidrug resistant cancers show improved potency and are largely unaffected by common modes of drug resistance.
Pipeline development

We initiated a new discovery program targeting metabolic disorders.
Fintech

We founded a wholly owned fintech subsidiary, BlockRules, that is developing transformative blockchain technology to power our preferred share offering on the blockchain (see post-period events).
Post-period events:

Changed London Stock Exchange ticker to VERS.
Closed common share subscription raising $10.7 million from existing shareholders.
On March 18, 2019, announced intention to undertake a preferred share offering in 2019, backed by a prospectus and with transactions recorded on the blockchain (a security token offering). Once live, this global offering will enable us to accelerate the development of our diverse drug pipeline.